The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
302
Aripiprazole tablet 10 mg po qd x 42 days
Aripiprazole tablet 30 mg po qd x 42 days
Placebo tablet po qd x 42 days
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Time frame: Baseline and Day 42
Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward. Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Time frame: Baseline and Day 42
Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward. Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Time frame: Baseline and Day 42
Change in Clinical Global Impression (CGI) Severity Score
Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Time frame: Baseline and Day 42
Clinical Global Impression (CGI) Improvement Score
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Last observed post-baseline value in CGI improvement score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Time frame: Baseline and Day 42
Change in Children's Global Assessment Scale (CGAS) Score
Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward. Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Time frame: Baseline and Day 42